Two-wrist data gathering system

ABSTRACT

Sensing is carried out from locations at considerable remove from the stomach. Cooperating sensor electronics are placed at each of two wrists of the patient. The potential discomfort and inconvenience of an abdominal patch are reduced or eliminated. And alternative power sources become available.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority pursuant to 35 U.S.C. §119 to U.S.application Ser. No. 61/300,435 filed Feb. 1, 2010, and entitled“Two-wrist data-gathering system”. The foregoing is incorporated byreference in its entirety.

INTRODUCTION

It is not easy to know whether a patient has taken his or hermedication.

The assignee of the present invention has given much attention in recentyears to ways of detecting ingestion of medications such as pills.Through great effort, the assignee of the present invention has devisedsystems involving pills each containing a device with communicationmeans, e.g., conductive communication means, etc., and involving areceiver such as a patch applied to the skin of a patient, so that whenone of the pills reaches the stomach, gastric acids activate the devicewhich communicates a current signature. The patch picks up the currentsignature, thus detecting the ingestion of the pill. The patch can thenpass along this event to other equipment and systems. For example thepatch may use a Bluetooth protocol to send news of the event to a mobiletelephone, which in turn can pass the event to other equipment. Atypical patch location is the abdomen.

While the assignee of the present invention has had good results in itssystems that use a patch in this way, the patch is sometimesinconvenient. It may be uncomfortable. It needs to be able to beflexible, since it adheres to skin that flexes. It is not easy toprovide much of a man-machine interface (“MMI”) on a patch located atthe abdomen. Keyboards and displays are not very workable if they are ona planar surface adhered to the abdomen.

An abdominal patch has a power source, typically a battery orelectrochemical cell (here for convenience of reference we will use theterm “cell” to refer both to multicell batteries and to single cells).The cell has only a limited service life, defined in large part by thecapacity of the cell and by the energy budget of the patch. When thebattery is run down, the patch needs to be taken out of service and adifferent patch needs to be put into service. This can also beinconvenient.

When the pill gets triggered, it emits a signal, sends a communication,etc. . . . An exemplary pill and communication are described in detailin, for example, in the following US patent publications:

U.S. Publication Publication No. date Title 2008/0,284,599 Nov. 20, 2008Pharma-informatics system 2008/0,306,359 Dec. 11, 2008 Medicaldiagnostic and treatment platform using near-field wirelesscommunication of information within a patient's body 2009/0,082,645 Mar.26, 2009 In-body device with virtual dipole signal amplification2009/0,227,204 Sep. 10, 2009 Pharma-informatics system 2010/0,022,836Jan. 28, 2010 In-body device having a multi-directional transmitter2010/0,081,894 Apr. 1, 2010 Communication System with Partial PowerSource 2010/0,312,188 Dec. 9, 2010 Pharma-informatics systemeach of which is incorporated herein by reference for all purposes as ifreproduced fully within. Actual tests with real pills, real patches, andreal human subjects have achieved reliable detection of communicationsfrom such pills. This is remarkable given prior-art failures to achievesuch reliable detection, and the many ways in which nature, humanphysiology, and materials science conspire to make these resultsdifficult to achieve.

As a general matter, conventional electromagnetic radiation is emittedby a dipole and detected and received by a dipole, and conventionalmodels assume that the signal strength falls away with distance at arate determined by the permittivity and permeability of the medium(here, human tissue). Many investigators in this general area thusproceed with the assumption that the receiver, such as a patch, needs tobe as nearby as possible to the transmitter (that is, nearby to thestomach).

It would be very desirable if some way could be found to detect thetriggering of the pill transmitters that would avoid the inconveniencesrelated to patches as just described, while nonetheless achieving thereliable detection that has been accomplished using patches. There areother physiological measurements that would also be desirable to carryout if only it could be accomplished reliably and accurately withoutundue discomfort or inconvenience to the patient.

SUMMARY

It is very counter-intuitive to carry out sensing from locations atconsiderable remove from the stomach, given that in general one mightthink the receiver needs to be as close as possible to the transmitter.And yet that is precisely what is described here. Cooperating sensorelectronics are placed at each of two wrists of the patient. Once thecounter-intuitive nature of this arrangement is put out of mind, otherpotential benefits become readily available, for example a man-machineinterface can be provided. The potential discomfort and inconvenience ofan abdominal patch are reduced or eliminated. And alternative powersources become available.

DESCRIPTION OF THE DRAWING

The invention is described with respect to a drawing in several figures,of which:

FIG. 1 shows a patient 101 with a wristwatch 102 and a bracelet 103according to an aspect of the invention;

FIG. 2 shows the wristwatch 102 with elastic band 203;

FIG. 3 shows the bracelet 103 with elastic band 203;

FIG. 4 shows the wristwatch 102 in cross section, with electrode 202 inintimate juxtaposition with wrist 105, and with chip 401;

FIG. 5 shows the bracelet 103 in cross section, with electrode 302 inintimate juxtaposition with wrist 106, and with chip 501;

FIG. 6 shows chip 401 in functional block diagram form; and

FIG. 7 shows chip 501 in functional block diagram form.

To the extent possible, like elements have been denoted with likereference numerals.

DETAILED DESCRIPTION

FIG. 1 shows a patient 101 with a wristwatch 102 and a bracelet 103according to an aspect of the invention. Wristwatch 102 is on rightwrist 105 and bracelet 103 is on left wrist 106. (It will be appreciatedthat this left-right arrangement is quite arbitrary and one couldexchange the positions of the wristwatch and bracelet without departingfrom the invention.) One of the chief goals is to detect a transmittedsignal or communication from pill 104 when it is triggered by gastricjuices.

It will be appreciated that while this invention is described in anexemplary aspect where stomach juices trigger the pill, other variantscould be devised such as aspects where the triggering does not occuruntil the pill reaches, say, the small intestine. One could also devisea staged approach where a first signal is triggered at a first point ofprogress through the gastro-intestinal system and a second signal istriggered at a second point of progress.

Turning now to FIG. 2, we see an exemplary wristwatch 102 with elasticband 203. The elastic band helps to keep the electrode 202 in intimatecontact with skin of the patient. A display 204, such as an LCD, isshown. A pushbutton 205 is also shown. In this way a man-machineinterface (MMI) is provided. It will be appreciated, of course, that theMMI need not be limited to what is shown here. Other elements of an MMI,such as a piezo beeper or other sound source, could be provided. A touchscreen or other human input device (HID) could be used. The LCD andpushbutton are merely exemplary.

While this aspect is described with respect to elastic wristbands, otherapproaches such as a Speidel Twist-o-flex® watchband could be employedto keep each skin electrode in intimate contact with the skin.

FIG. 3 shows the bracelet 103 with elastic band 203. The elastic bandkeeps electrode 302 in intimate contact with skin of the patient.

In the exemplary arrangements that follow, the electrodes 202, 302 willbe described as electrodes in intimate (conductive) contact with skin.Perhaps less preferred, but also workable, would be electrodes 202, 302in capacitive coupling with skin, that is, with some dielectric such asplastic film therebetween. Perhaps even less preferred, but maybe alsoworkable, would be an arrangement in which the wristband 203 is notelastic at all but is of constant circumference, permitting theelectrodes 202, 302 to be in a spaced relationship relative to skin,sometimes having an air gap or partial air gap therebetween.

FIG. 4 shows the wristwatch 102 in cross section, with electrode 202 inintimate juxtaposition with wrist 105, and with chip 401. Chip 401 iscommunicatively coupled, preferably metallically connected, with skinelectrode 202 and with a second electrode 402. The second electrode 402is open to the air, and provides what might be modeled as a counterpoisefor the skin electrode 202. A nonconductive casing 403 providesstructure between the two electrodes. FIG. 5 shows the bracelet 103 incross section, with electrode 302 in intimate juxtaposition with wrist106, and with chip 501 in communicative coupling with skin electrode 302and second electrode 502. The bracelet electrodes together with housingor casing 503 function similarly to their counterparts in thewristwatch.

FIG. 6 shows wristwatch chip 401 in functional block diagram form.Previously mentioned electrodes 202, 402 may be seen, communicativelycoupled with transceiver 605. Cell 603 and power circuitry 604 providepower to transceiver 605 and to controller 606. Controller 606 controlstransceiver 605 and provides MMI such as LCD 204 and pushbutton 205, andoptionally other MMI such as a piezo beeper or other sound emitter. LCD204 is controlled by multiline bus 607.

Interestingly, a technology that seems rather old-fashioned, theself-winding mechanical watch, offers possible benefits here. As shownin FIG. 6, a pendulum 601 has an opportunity to move around as the humanuser moves around. A strong permanent magnet in the pendulum inducescurrents in a winding or windings 602. This permits the cell 603 to be arechargeable cell, or perhaps an ultracapacitor, mediated by powercircuitry 604. Bluetooth or other protocol system(s) 607 can communicatewith external equipment such as a cell phone or personal computer.

FIG. 7 shows bracelet chip 501 in functional block diagram form. Theelements shown there correspond closely with elements in FIG. 6.

The day-to-day function of the system (the pills, the bracelet, thewristwatch, and other equipment such as a mobile phone) will now bedescribed in an exemplary aspect.

A chief goal is to detect, at the bracelet 103 and wristwatch 102, asignal from a pill. To this end, the bracelet may carry out a real-timenearly continuous detection of signals at the skin electrode 302relative to counterpoise 502. This detection is A-to-D(analog-to-digital) converted, e.g., by an ADC (not shown in FIG. 7),preferable at a resolution higher than 16 bits, and the measured signal(communicated digitally and preferably as compressed data) iscommunicated via a wireless link to the wristwatch 102. The wristwatchlikewise carries out a real-time nearly continuous detection of signalsat the skin electrode 202 relative to counterpoise 402. This detectionis A-to-D (analog-to-digital) converted, preferable at a resolutionhigher than 16 bits. The data streams from the two sensors (one at thebracelet, one at the wristwatch) are then communicated externally toother equipment that can do signal processing and can detect signals ofinterest such as the signal from the pill when it is triggered.

In a preferred arrangement, all of the noise would be common-mode andthe signals of interest would be differential signals measured at thetwo arms.

As mentioned above, it is rather counterintuitive to take the step ofmoving the sensors to points that are about as far from the pill 104 ascan be imagined. Once the counterintuitive nature of this move isaccepted and put out of mind, many other interesting capabilities becomeavailable that would likely not have been available at all in prior-artarrangements such as an abdominal patch.

Technology suitable for such sensing is discussed in a paper entitled “Alow-noise, non-contact EEG/ECG sensor” by Thomas J Sullivan, Stephen R.Deiss, and Gert Gauwenberghs of the University of California, San Diego,Biomedical Circuits and Systems Conference, 2007, BIOCAS 2007, IEEE,27-30 Nov. 2007 Pages 154-157, Digital Object Identifier10.1109/BIOCAS.2007.4463332, incorporated herein by reference.

Sensing things from further away from the body is discussed in PCTpublication WO 2009/055733 entitled “Fluid transfer port informationsystem”, incorporated herein by reference, and in US publishedapplication US 2009-0112178 A1 with the same title, likewiseincorporated herein by reference. Sensing blood volume is discussed inU.S. patent application No. 61/160,265 filed Mar. 13, 2009 and entitled“Volume-sensing device, system, and method”, incorporated herein byreference. Other related technology is discussed in US patentapplication No. 61/240,571 filed Sep. 8, 2009 and entitled“Body-associated device”, incorporated herein by reference.

As one potential benefit mentioned above, the move to the wrists permitsthe provision of a workable MMI. Wrists also tend to move around morethan abdomens, making the self-winding feature more likely to serve itspurpose.

More subtle and interesting capabilities, however, present themselvesonce the stimulus/sensing platform of a bracelet and wristwatch areavailable.

The heart function (essentially a two-electrode EKG) can be measured.

Energy can be transmitted at one of the two points (for example at thebracelet) at some frequency, which propagates through the body to theother point (in this example at the wristwatch) with some measured delayand some measured level of absorption, or measured impedance.Separately, energy can be transmitted at one of the two points (againfor example at the bracelet) at a different frequency, which propagatesthrough the body to the other point (again in this example at thewristwatch) with a non-identical measured delay and a non-identicalmeasured level of absorption, or measured impedance. This probing of thebody amounts to spectroscopy, and permits measuring bodily qualitiessuch as amount of fluid in the body relative to other tissue materials.In this way, blood volume can be indirectly measured. Real-timemeasurement of blood volume has rarely if ever been achieved except bykeeping a patient stationary during measurements, with large, bulky, andstationary measuring equipment. This approach permits real-timemeasurement even as a patient is ambulatory.

These measurements may permit real-time measurement of cardiac output orstroke volume at the heart.

It will be appreciated that one of the important parts of analysis ofdata collected at electrodes 202, 302 (at the bracelet and at thewatchband) is the time-correlation of measured data. One might thinkthat this requires a highly accurate clock running in each of thebracelet and watchband, the two clocks being extremely closelysynchronized.

But in fact it is quite workable to allow the two clocks to be lessexpensive (and less power-hungry) clocks that are permitted to driftrelative to each other. At the wristwatch, synchronization events(simultaneous detection of common-mode impulse signals from theenvironment, for example) permit receiving a time signal from thebracelet which will then be understood to match a time value at thewristwatch. Drift of one clock relative to the other can be detected andcorrected in this way.

The wristwatch and bracelet can be stylish. They need not look “clunky”.The patient might actually enjoy wearing a recognizable or distinctivewristwatch and bracelet.

The A-to-D conversions at the two sensing locations are likely 18-bit,but might be sixteen-bit or twelve-bit.

Communication from the bracelet to the wristwatch might be open-loop(one way from bracelet to watchband) but it is thought preferable thatthe communication be bidirectional, at least to provide handshaking.

The communication may use an inductive coupling through the body at ahigh-frequency RF signal (higher than the sensed information that isexpected to be in the range of 0.1 Hz to perhaps 100 Hz). Alternativelythe communication can be optical infrared (bouncing off the surroundingwalls and structures).

The MMI might provide a reminder to take a particular pill. And the MMImight provide an audible or visual acknowledgment when the patient hastaken a particular pill.

Accelerometers in the bracelet or watchband or both will permitmeasurement of a physical activity level, and may permit detecting timesof sleep. These could likewise be reported external to the patient.

The allocation of computational resources can be varied somewhat. Forexample it may be workable to do most of the computations in thewristwatch, comparing the signals as measured at the bracelet and at thewristwatch. Alternatively it is workable to do the computationselsewhere (e.g. at a distant computer) and to have the wristwatch simplypass along the information which it received from the bracelet.

The needed bandwidth from bracelet to wristwatch, and from wristwatch todistant equipment, is such at a carrier of 10 MHz should be adequate.

The alert reader will have no difficulty devising myriad obviousimprovements and variants of the invention, all of which are intended tobe encompassed by the claims which follow.

1. A data gathering method carried out with respect to a first device and a second device, each of the first device and the second device comprising a respective electrical signal detector having respective first and second electrodes, the method comprising the steps of: placing a first device upon a first limb of a living body, the first device encircling said first limb, the first electrode of the first device juxtaposed with said first limb, the second electrode of the first device more distant from the first limb than the first electrode; placing a second device upon a second limb of a body, the second device encircling said second limb, the second limb being a limb other than the first limb, the first electrode of the first device juxtaposed with said second limb, the second electrode of the second device more distant from the second limb than the first electrode; at the first device, measuring electrical signals at the respective signal detector differentially between the respective first and second electrodes, yielding a first data stream indicative thereof; at the second device, measuring electrical signals at the respective signal detector differentially between the respective first and second electrodes, yielding a second data stream indicative thereof; and analyzing the first data stream and the second data stream together, thereby deriving information of interest about the body.
 2. The method of claim 1 wherein the analyzing step further comprises synchronizing the first data stream to the second data stream by aligning common-mode events therein.
 3. The method of claim 1 wherein the analyzing step is carried out at equipment separate from the first device and separate from the second device, the method further comprising the steps of: communicating the first data stream from the first device to the equipment, and communicating the second data stream from the second device to the equipment.
 4. The method of claim 1 further characterized in that the first limb is a first arm of the body, and the second limb is a second arm of the body, and wherein the encircling of the first device comprises encircling a wrist of the first limb, and wherein the encircling of the second device comprises encircling a wrist of the second limb.
 5. The method of claim 1 wherein the analyzing step comprises detecting at least one of a signal and a communication associated with an ingestible device ingested by the body.
 6. The method of claim 1 wherein the first device has a rechargeable energy storage, the method further comprising the step of moving the first limb, and converting movement of the first limb into electrical energy, said electrical energy recharging the rechargeable energy storage.
 7. The method of claim 6 further comprising the steps of: inferring a level of physical activity of the body from the converted electrical energy, and communicating the inferred level of physical activity external to the first device and external to the second device.
 8. The method of claim 1 wherein the measuring of electrical signals at the first device comprises carrying out an analog-to-digital conversion, the first data stream being digital, and wherein the measuring of electrical signals at the second device comprises carrying out an analog-to-digital conversion, the second data stream being digital.
 9. The method of claim 8 wherein the analog-to-digital conversions take place with a resolution of at least sixteen bits.
 10. The method of claim 1 wherein the analyzing step comprises carrying out an electrocardiogram measurement with respect to a heart of the body.
 11. The method of claim 1 further comprising the steps of: emitting first electrical energy within a first band at the first device; detecting the first electrical energy at the second device; emitting second electrical energy within a second band at the first device, the second band different from the first band; detecting the second electrical energy at the second device; and comparing the detected first electrical energy and the detected second energy with each other, thereby deriving information of interest about the body.
 12. The method of claim 11 wherein the step of deriving information of interest about the body comprises inferring a ratio of fluid to non-fluid within the body.
 13. The method of claim 11 wherein the step of deriving information of interest about the body comprises inferring blood volume within the body.
 14. The method of claim 1 further comprising the step of: communicating the first data stream from the first device to the second device; wherein the analyzing step is carried out within the second device.
 15. The method of claim 14 wherein the communicating step is carried out by means of infrared light communications or by means of high frequency radio frequency communications.
 16. A system comprising a first device and a second device, the first device comprising a respective electrical signal detector having respective first and second electrodes; the second device comprising a respective electrical signal detector having respective first and second electrodes; the first device shaped for encircling a limb of a subject, the first electrode of the first device disposed to be juxtaposed with said limb when the first device encircles the limb, the second electrode of the first device disposed to be more distant from the limb than the first electrode when the first device encircles the limb; the second device shaped for encircling a limb of a subject, the first electrode of the second device disposed to be juxtaposed with said limb when the second device encircles the limb, the second electrode of the second device disposed to be more distant from the limb than the first electrode when the second device encircles the limb; the electrical signal detector of the first device responsive to signals at the respective first and second electrodes, yielding a first data stream indicative of a difference between the signals at the respective first and second electrodes; the electrical signal detector of the second device responsive to signals at the respective first and second electrodes, yielding a second data stream indicative of a difference between the signals at the respective first and second electrodes; the system further comprising an analysis means, said means responsive to the first data stream and the second data stream, for deriving information of interest about the body.
 17. The system of claim 16 where the analysis means is separate from the first device and separate from the second device, the system further comprising: a communications link from the first device to equipment, and a communications link from the second device to the equipment.
 18. The system of claim 16 wherein the first device further comprises a rechargeable energy storage, the first device further comprising a means converting movement into electrical energy, said electrical energy recharging the rechargeable energy storage.
 19. The system of claim 18, wherein the analysis means infers a level of physical activity of the body from the converted electrical energy, and communicates the inferred level of physical activity external to the first device and external to the second device.
 20. The system of claim 16 wherein the first device further comprises an analog-to-digital converter converting analog signals from the respective first and second electrodes into digital data, the first data stream comprising said digital data.
 21. The system of claim 19 wherein the analog-to-digital converter has a resolution of at least sixteen bits.
 22. The system of claim 16 wherein the first device comprises an emitter controllably emitting first electrical energy within a first band at the first device and controllably emitting second electrical energy within a second band at the first device, the second band different from the first band; and wherein the second device comprises a detector disposed to detect first electrical energy and the second electrical energy; the analysis means disposed to compare the detected first electrical energy and the detected second energy with each other, thereby deriving information of interest.
 23. The system of claim 16 wherein the first device communicates the first data stream to the second device; and wherein the analyzing means is within the second device.
 24. The system of claim 23 wherein communicating is carried out by means of an infrared light communications channel or by means of a high frequency radio frequency communications channel. 